Associate Director of Analytical Development

14 hours ago


Waltham, Massachusetts, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled and experienced Associate Director to lead our Analytical Development team. As a key member of our Strategic External Development organization, you will be responsible for developing, manufacturing, and characterizing drug substances and drug products.

Key Responsibilities
  • Lead a team of analytical scientists in the development, manufacturing, and release of drug substances and drug products.
  • Develop and execute strategies for analytical development, including process characterization and product quality assessment.
  • Collaborate with cross-functional teams to ensure strong process and product development and characterization.
  • Author, review, and approve key source documents for regulatory filings.
  • Lead and track analytical development commitments to support CMC filing activities.
Requirements
  • M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience.
  • 10 or more years of analytical development experience, including 3 or more years of people management and analytical project leadership experience.
  • 5 or more years of experience in analytical assay development, qualification, and validation.
  • 2 or more years of experience in methods tech transfer and life cycle management.
Preferred Qualifications
  • Exposure to all stages of drug development.
  • Proven ability to manage projects and work with cross-functional teams.
  • Experience with mRNA, peptides, and conjugated biologic therapeutics modalities.

GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.



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